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Proton Beam Therapy

MRI-Guided Prostate Boosts for Prostate Cancer (BLaStM Trial)

N/A
Recruiting
Led By Alan Pollack, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason score 6-10
No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.25 years (post-treatment)
Awards & highlights

Summary

This trial is testing a new, more effective radiation treatment for prostate cancer. The hope is that it will improve cancer control and quality of life by reducing damage to nearby organs.

Who is the study for?
Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.Check my eligibility
What is being tested?
The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, fatigue, urinary issues like increased frequency or urgency, bowel changes such as diarrhea or rectal bleeding, and sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has a Gleason score between 6 and 10.
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I have not had a complete prostate removal surgery.
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I am between 35 and 85 years old.
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My prostate cancer is confirmed by biopsy.
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My cancer is in an early to mid-stage according to a physical exam.
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My cancer has not spread to other parts of my body according to tests.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of disorders related to lymphocyte proliferation.
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I have a history of cancer.
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I do not have any active cancer except for non-spreading skin cancer or early chronic lymphocytic leukemia.
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I have had my prostate completely removed.
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I am younger than 35 or older than 85 years old.
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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.25 years (post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years (post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Early Prostate Tumor Response (EPTR)
Secondary outcome measures
Change in CTC Levels
Change in gene/biomarker expression
Correlation between EPTR and Changes in serial post-RT MRIs
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: LEAD RT GroupExperimental Treatment1 Intervention
Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.
Group II: HEIGHT RT GroupExperimental Treatment1 Intervention
Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
918 Previous Clinical Trials
412,465 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,757 Patients Enrolled for Prostate Cancer
Alan Pollack, MD, PhD5.02 ReviewsPrincipal Investigator - University of Miami
University of Miami
5 Previous Clinical Trials
2,435 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,435 Patients Enrolled for Prostate Cancer
5Patient Review
Dr. Pollack is a highly skilled researcher who will go above and beyond to ensure your needs are met. He's compassionate and competent — a rare find in the medical field today.

Media Library

HEIGHT RT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02307058 — N/A
Prostate Cancer Research Study Groups: HEIGHT RT Group, LEAD RT Group
Prostate Cancer Clinical Trial 2023: HEIGHT RT Highlights & Side Effects. Trial Name: NCT02307058 — N/A
HEIGHT RT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02307058 — N/A
~40 spots leftby Jul 2027